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DTSTAMP:20240328T220835Z
UID:1d999aad-6d19-4ef3-93e9-a7167429c289
DTSTART:20210118T100000
DTEND:20210119T100000
CLASS:PRIVATE
DESCRIPTION:Overview:  \;
\nThis webinar details the regulation an
d how it applies to computerized systems. Learn exactly what is needed to
be compliant for all three primary areas: SOPs for the IT infrastructure\,
industry standards for software product features\, and the 10-step risk-b
ased validation approach.
\n
\nAreas Covered in the Session:
\nWhich data and systems are subject to Part 11
\nWhat Part 11 mean
s to you\, not just what it says in the regulation
\nAvoid 483 and Wa
rning Letters
\nExplore the three primary areas of Part 11 compliance
: SOPs\, software product features\, and validation documentation
\nE
nsure data integrity\, security\, and protect intellectual property
\
n
\nWho Will Benefit:
\nIT
\nQA
\nQC
\nLaboratory
Staff
\nManagers
\nGMP\, GCP\, GLP Professionals
\n
\
nSpeaker Profile:
\nEdwin Waldbusser is a consultant retired from ind
ustry after 20 years in management of development of medical devices (5 pa
tents). He has been consulting in the US and internationally in the areas
of design control\, risk analysis and software validation for the past 8 y
ears.
\n
\nContact Detail:
\nCompliance4All DBA NetZealous\
,
\nPhone: +1-800-447-9407
\nEmail: support@compliance4All.com
SUMMARY:Which data and systems are subject to Part 11
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SUMMARY:Which data and systems are subject to Part 11
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